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Bioavailability of Vitamin D Photoisomers From UVB-exposed Button Mushrooms

NCT ID: NCT05668832

Last Updated: 2022-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-09

Study Completion Date

2024-07-30

Brief Summary

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The European Food Safety Authority has approved many applications for UVB light treated foods (e.g. UVB-exposed button mushrooms) in the last years. The UVB light treatment is used to increase the vitamin D content in foods and improve the vitamin D status of subjects. However, UVB irradiation is accompanied by the formation of vitamin D photoisomers such as lumisterol and tachysterol. The current study aims to investigated whether these vitamin D photoisomers can enter the circulation and are metabolised in humans that consume UVB-treated mushrooms.

Detailed Description

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according to protocol

Conditions

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Dietary Exposure Safety Issues

Keywords

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lumisterol tachysterol hydroxy-photoisomers vitamin D

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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oral intake of UVB-exposed mushrooms

Daily intake of 500 g of UVB-exposed button mushrooms over 7 days (provided as mushroom cream soup) and blood sampling (at baseline, 3 h postprandial, 6 h postprandial and at day 8)

Group Type EXPERIMENTAL

UVB-exposed button mushrooms

Intervention Type DIETARY_SUPPLEMENT

Healthy subjects will be randomized into two groups and received either UVB-exposed button mushrooms or non-UVB-exposed button mushrooms for 7 days. Blood samples from each subject will be taken at baseline (before the intake of the mushrooms, 3 h and 6 h thereafter, and at day 8. Three months later, another blood sample was taken.

oral intake of non-UVB-exposed mushrooms

Daily intake of 500 g of non-UVB-exposed button mushrooms over 7 days (provided as mushroom cream soup) and blood sampling (at baseline, 3 h postprandial, 6 h postprandial and at day 8)

Group Type PLACEBO_COMPARATOR

UVB-exposed button mushrooms

Intervention Type DIETARY_SUPPLEMENT

Healthy subjects will be randomized into two groups and received either UVB-exposed button mushrooms or non-UVB-exposed button mushrooms for 7 days. Blood samples from each subject will be taken at baseline (before the intake of the mushrooms, 3 h and 6 h thereafter, and at day 8. Three months later, another blood sample was taken.

Interventions

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UVB-exposed button mushrooms

Healthy subjects will be randomized into two groups and received either UVB-exposed button mushrooms or non-UVB-exposed button mushrooms for 7 days. Blood samples from each subject will be taken at baseline (before the intake of the mushrooms, 3 h and 6 h thereafter, and at day 8. Three months later, another blood sample was taken.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects
* Age between 18 and 65 years
* Body Mass Index in the range of 18.5 to 29.9 kg/m2

Exclusion Criteria

* Acute or chronic illnesses (high blood pressure, heart disease, diabetes, kidney disease, liver disease, alcohol dependence, etc.)
* Taking medication (except oral contraceptives)
* Pregnancy or breastfeeding
* Food intolerances or allergies to mushrooms and dairy products
* Smokers
* Visits to solariums or previous holidays in southern countries or in the Alps or other high mountains
* Participation in another study
* Blood donation during the last 2 months before the start of the study
* Dieting
* Severe weight loss or weight loss (≥ 3 kg) within the last month
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Martin-Luther-Universität Halle-Wittenberg

OTHER

Sponsor Role lead

Responsible Party

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Gabriele Stangl

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gabriele I Stangl, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Martin-Luther-Universität Halle-Wittenberg

Central Contacts

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Gabriele I Stangl, Prof. Dr.

Role: CONTACT

Phone: +493455522707

Email: [email protected]

Other Identifiers

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UHalle 2022-123

Identifier Type: -

Identifier Source: org_study_id